Sterile medical device

For these devices ISO 13485 adds requirements on sterilization process validation, records for each sterilization batch and the sterile barrier system. The required level of sterility comes from the applicable regulations and standards.

medical device intended to meet the requirements for sterility Note 1 to entry: The requirements for sterility of a medical device can be subject to applicable regulatory requirements or standards.

ISO 13485:2016, clause 3.20